Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit.
The alert says that particulates could enter the bloodstream and become lodged in vessels. The affected items are specific kits identified by lot numbers and include the Namic manifolds.
Medical Action Industries sent a letter on May 13 advising customers to check inventory, quarantine, and destroy the affected kits after completing recall forms. Over‑labels should be applied to any remaining kits stating that the manifolds must be removed.
If the kits cannot be removed because patient care would be compromised, users must flush the manifolds and tubing with saline and monitor closely.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: Convenience Kit Issue from Medical Action Industries”
read at fda medwatch ↗
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